NCT04188210

Brief Summary

The study will include the patients undergoing hemodialysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
Last Updated

December 5, 2019

Status Verified

November 1, 2019

Enrollment Period

1 month

First QC Date

November 29, 2019

Last Update Submit

December 3, 2019

Conditions

Keywords

musculoskeletal painelbow painhemodialysis

Outcome Measures

Primary Outcomes (1)

  • Kolmogorov-Smirnov test

    All data for normality was tested by using Kolmogorov-Smirnov test

    through study completion, an average of 1 month

Interventions

The Beck Depression Inventory (BDI), the Nottingham Health Profile (NHP) scores were measured for all patients to evaluate depression symptoms and health-related quality of life. The elbow pain presence was asked to all the patients, the patients with elbow pain were also evaluated with The Disabilities of the Arm, Shoulder and Hand Score (Q-DASH) and Visual Analogue Scale (VAS). VAS detected as pain during rest, activity, night and pain at last week.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the patients with end stage renal disease

You may qualify if:

  • being over 18 years old having hemodialysis treatment

You may not qualify if:

  • any surgical operation at upper extremity in last 3 months, the presence of conditions such as cancer, chronic hearing loss and neurologic diseases can affect the interview.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Balkan Hospital

Kırklareli, 39750, Turkey (Türkiye)

Location

Related Publications (2)

  • Fidan F, Alkan BM, Tosun A, Altunoglu A, Ardicoglu O. Quality of life and correlation with musculoskeletal problems, hand disability and depression in patients with hemodialysis. Int J Rheum Dis. 2016 Feb;19(2):159-66. doi: 10.1111/1756-185X.12171. Epub 2013 Oct 31.

  • Kane SF, Lynch JH, Taylor JC. Evaluation of elbow pain in adults. Am Fam Physician. 2014 Apr 15;89(8):649-57.

MeSH Terms

Conditions

Kidney Failure, ChronicMusculoskeletal Pain

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • betül tepeli

    private balkan hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Physical Medicine And Rehabilitation, Private Balkan Hospital,Principal Investigator,

Study Record Dates

First Submitted

November 29, 2019

First Posted

December 5, 2019

Study Start

March 1, 2019

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

December 5, 2019

Record last verified: 2019-11

Locations